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Friday, June 28, 2013

EU CHMP recommends ten new medicine for approval including two first two monoclonal antibody biosimilars

In one of the busiest CHMP
meetings of 2013 so far, the Committee recommended ten new medicines
for approval, including the first two monoclonal antibody biosimilars,
and a new advanced therapy medicine. These medicines are intended for
patients suffering from diseases including cancer, multiple sclerosis
and other auto-immune diseases.

Ten new medicines recommended for approval

The CHMP recommended granting of marketing authorisations for the first two monoclonal antibody biosimilars. Remsima and Inflectra are recommended for authorisation in the same indications as Remicade
(infliximab), a monoclonal antibody that has been authorised in the
European Union (EU) since 1999.

Three medicines to treat cancer received positive opinions from the CHMP:

1) Provenge,
a cell-based therapy for the treatment of metastatic castrate-resistant
prostate cancer, which is also the fourth advanced therapy medicinal product to be recommended for marketing authorisation by the CHMP;

2) Tafinlar, for the treatment of unresectable or metastatic melanoma with a BRAF V600 mutation; and

3) Stivarga for the treatment of metastatic colorectal cancer.

4) Procysbi (Cysteamine) for the management of cystinosis

5) Lemtrada (Alemtuzumab) for the treatment of multiple sclerosis.

6) Cholib (Fenofibrate / simvastatin)
as adjunctive therapy to diet and exercise, to reduce triglycerides and
increase HDL-cholesterol levels in adults with mixed dyslipidemia with
high cardiovascular risk

7)Nexium Control for the short-term treatment of reflux symptoms in adults,

8) Evarrest for the treatment of haemostasis, and as an adjunct to haemostasis.

Re-examination of two initial recommendations for marketing authorisation

The CHMP adopted a positive re-examination opinion for Aubagio, revising its previous opinion not to grant new active substance status to the medicine at its March 2013 meeting.

The CHMP adopted a final negative opinion following the re-examination of Labazenit.

Five recommendations for extensions of indications

The CHMP recommended an extension of the existing indication for Eylea, Evicel, Onglyza, Velcade and Zonegran.

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